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Trial record 4 of 4 for:    desai mehul

Epidural Contrast Flow Patterns of TESI Using the Inferior-Anterior Position as the Final Needle Tip Position.

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ClinicalTrials.gov Identifier: NCT01836770
Recruitment Status : Terminated (lack of enrollment; terminated by the Principal Investigator)
First Posted : April 22, 2013
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
George Washington University

Brief Summary:

The purpose of this study is to describe the contrast flow patterns in the epidural space using the inferior-anterior approach with continuous fluoroscopic guidance, and determine how well this approach correlates with appropriate contrast flow patterns and with analgesia at follow up. This knowledge may prove useful in guiding physician practice patterns in the non-surgical management of low back pain.

Hypothesis: The investigators hypothesize that there will be suitable (ventral/anterior) epidural contrast spread based on inferior-anterior needle-tip position, particularly with appropriate needle tip position.


Condition or disease
Lumbosacral Radiculopathy Lumbar Herniated Nucleus Pulposus

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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidural Contrast Flow Patterns of Transforaminal Epidural Steroid Injections Using the Inferior-Anterior Position as the Final Needle Tip Position.
Actual Study Start Date : August 2010
Actual Primary Completion Date : June 20, 2013
Actual Study Completion Date : June 20, 2013

Group/Cohort
Transforaminal Epidural Steroid Injection
Patients with a history of lumbosacral radiculopathy or lumbar herniated nucleus pulposus, scheduled for Transforaminal Epidural Steroid Injection.



Primary Outcome Measures :
  1. Contrast flow patterns [ Time Frame: 3 Months ]
    Contrast flow patterns will be used as the primary outcome measure. The statistical test to be employed is to compare the proportions of patients in the study who experienced posterior flow, anterior flow and if that anterior flow had spread to more than 1 vertebral level in either direction, what that direction was, and the presence or absence of vascular flow.


Secondary Outcome Measures :
  1. VAS pain score [ Time Frame: 3 months ]
    VAS Pain Score - The statistical test to be employed is Wilcoxon Signed Rank Test to compare if there is a difference in pain score at appointments 1 months and 3 months post-injection relative to pre-injection.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
George Washington Spine and Pain Center patients.
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • History of lumbosacral radiculopathy or lumbar herniated nucleus pulposus
  • Scheduled for TFESI at GW Spine and Pain Center

Exclusion Criteria:

  • Pregnant or plan on becoming pregnant
  • Have undergone TFESI in the past year
  • Opioid habituation
  • Lumbo-sacral stenosis
  • Lumbar surgery
  • Lumbar spondylolisthesis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836770


Locations
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United States, District of Columbia
George Washington Spine and Pain Center
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University
Investigators
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Principal Investigator: Mehul J Desai, MD MPH George Washington Spine and Pain Center

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Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT01836770     History of Changes
Other Study ID Numbers: Kambin
First Posted: April 22, 2013    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Keywords provided by George Washington University:
Transforaminal Epidural Steroid Injections
Additional relevant MeSH terms:
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Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases